MAUDE Adverse Event Report: EDWARDS LIFESCIENCES DR ACUMEN IQ CUFF ADULT; SYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE

Model Number	AIQCA
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	Unspecified Tissue Injury (4559)
Date of Event	06/24/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device will not be returned as it was discarded by the hospital.However, a supplemental report will be forthcoming once the engineering evaluation is completed.Complaint histories for all reported events are reviewed against trending control limits on a monthly basis and any excursions above the control limits are assessed and documented as a part of the monthly review.
Event or Problem Description
It was reported that after use of the acumen iq finger cuff, positioned adjacent to a finger with a pulse oximetry sensor, the patient developed a blister on their finger.No steps were taken intra-operatively to treat the blister.There was no other patient injury reported.
Additional Manufacturer Narrative
A clinical evaluation was completed on the provided photo.Image confirmed reported "burn type of blister on the palm (bottom) side of the finger." the review shows skin discoloration on the underside of the third digit (middle finger).Although the patient injury was confirmed through the image, it is not possible to determine if there is a failure associate to a manufacturing/design defect since no objective sample of the product was returned for investigation.Dhr review could not be performed since no lot number was provided.Based on available information, a definite root cause is unable to be determined at this time.As part of manufacturing control measures, all devices undergo a visual inspection, electrical test, and quality assurance sampling inspection.

• Brand Name: ACUMEN IQ CUFF ADULT
• Common Device Name: SYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE
• Manufacturer (Section D): EDWARDS LIFESCIENCES DR; parque industrial de itabo; carr. sanchez km 18.5; haina, san cristobal
• Manufacturer (Section G): EDWARDS LIFESCIENCE; 17200 laguna canyon rd; irvine CA 92618
• Manufacturer Contact: samantha eveleigh ; 17200 laguna canyon rd; irvine, CA 92618 ; 9492017706
• MDR Report Key: 22547569
• Report Number: 2015691-2025-05881
• Device Sequence Number: 8468361
• Product Code: DXN
• UDI-Device Identifier: 00690103219067
• UDI-Public: 00690103219067
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K230919
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/25/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: AIQCA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/25/2025
• Supplement Date Received by Manufacturer: 08/25/2025
• Initial Report FDA Received Date: 07/18/2025
• Supplement Report FDA Received Date: 08/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown